UL is proud to share New Science, a powerful initiative showcasing important ways we are making our world safer through fundamental discovery, testing methodologies, software and standards across five areas.

MEDICAL AND LABORATORY

UL provides comprehensive life cycle services to support the medical and laboratory industries in achieving global regulatory approvals.

Our industry-dedicated team are knowledge leaders in the full life cycle needs of the health sciences industries. Our customers gain the efficiency, expertise and cost benefits associated with working with an industry leader for all their critical business needs.

UL helps our customers prevent and resolve complicated quality issues that could lead to recalls, embargoes, bans and liability. We offer nonclinical testing; usability, EMC and performance testing; safety certification; and compliance training to help speed unrestricted access to the global market.

The benefits of working with ULUL’s in-depth knowledge of the issues driving regulatory efforts uniquely enables us to provide actionable insights to help our customers achieve compliance in all of their target markets.

UL works directly with government agencies around the globe to help inform health IT policy. Our technical experts are active members of industry standards writing and technical committees. We also have a cooperative research and development agreement (CRADA) with the U.S. Food and Drug Administration (FDA). Through this unique partnership, UL has provided the online training, documentation tracking and a 21 CFR Part 11-validated platform used to certify and train over 36,000 FDA inspectors worldwide.

Our global presences enables us to offer our customers a full suite of services in their own language and time zone as well as to provide access to local experts. We provide integrated quality system assessments to ease the process of meeting regulatory requirements for multiple countries.

We can provide our customers with comprehensive, customized learning management systems that can be integrated directly into their compliance and quality systems to further assist them in demonstrating compliance to regulators.

Globally, UL Registrar is ACLASS/ANAB Accredited by the ANSI-ASQ National Accreditation Board to provide the ACLASS Symbol for a variety of technical schemes, which highlights UL Registrar’s technical competence as a monitoring body. Throughout the world, many countries rely on a process called accreditation as a means of confirming the technical competence of inspection/audit bodies...

In February, the International Electrotechnical Commission (IEC) published the fourth edition of IEC 60601-1-2, a collateral standard that provides the requirements for essential performance and basic safety in the presence of electromagnetic disturbances. The standard introduces electromagnetic (EM) environments of “intended use”, including professional healthcare facilities and home healthcare. Although the FDA transition date is...

OSHA recently updated UL’s NRTL scope to include the standard AAMI ES60601-1 with Amendment 1, the safety standard for Medical Electrical Equipment. This standard with amendment 1 references the ISO 14971:2007 standard for risk management of medical devices. You can read the full scope of UL’s NRTL at: https://www.osha.gov/dts/otpca/nrtl/ul.html About the program (from the OSHA...

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Cloud computing learning solutions brought to you by UL that assure regulatory compliance, minimize risk and improve business performance. EduDirect is UL Quality, Compliance and Learning’s online e-learning program that includes over 80 courses reviewed by the Food and Drug Administration (FDA) on critical inspection and enforcement topics.

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UL is a global independent safety science company offering expertise across six key strategic businesses:
Commercial & Industrial, Environment, Information & Insights, Life & Health, Consumer
and Workplace Health & Safety. Our breadth, established objectivity and proven history mean we are a symbol
of trust, enabling us to help provide peace of mind to all.